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Effect of Probiotic Supplementation on Fecal Microbiota, Nutritional Status, Metabolic and Inflammatory Parameters in Patients With Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
Universidade Federal de Santa Catarina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age from 35 to 75 years old;
  • Individuals diagnosed with type 2 diabetes mellitus (at least 1 year ago);
  • Body mass index from 25.00 kg/m² to 39.99 kg/m²;
  • Glycated hemoglobin ≤ 9.0% ;
  • Using metformin, combined or not with other antidiabetic drugs

Exclusion Criteria:

  • Previous bowel diseases (inflammatory bowel disease and irritable bowel syndrome); or previous gastrointestinal surgery (eg, colectomy, gastrectomy)
  • Intolerances and ∕ or food allergies with a previous medical diagnosis (eg lactose intolerance or celiac disease);
  • Glomerular filtration rate <30 ml/min/1.73m²; inflammatory diseases and immunodeficiencies;
  • Diagnosis of autonomic neuropathy with gastrointestinal involvement such as: diabetic gastroparesis, diabetic enteropathy (diarrhea) or colonic hypomotility (constipation);
  • Hospital admission and/or use of anti-inflammatory drugs (non-hormonal and corticosteroids) up to 1 month before the study; and ∕or use of antibiotics up to 3 months before the study;
  • Regular use of laxatives, opioid narcotic analgesics or appetite suppressants;
  • Current or previous use (up to 1 month) of prebiotics, probiotics, symbiotics or products enriched with these food supplements;
  • Intolerance to prebiotics, probiotics or symbiotics;
  • Pregnant or breastfeeding;
  • Follow-up of a diet, guided by a nutritionist, for weight loss or gain up to 1 month before the study or current follow-up of unusual diets (eg vegetarian, macrobiotic, paleolithic);
  • Alcohol consumption (> 1 drink/day or 14g of alcohol for women; >2 drinks/day or 28 grams of alcohol for men); use of illicit drugs and smokers;
  • Change of lipid-lowering and/or antidiabetic drugs in the last 3 months

Sites / Locations

  • Polydoro Ernani de São Thiago University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Probiotic

Arm Description

Maltodextrin (1 capsule/day)

Probiotic (Bifidobacterium animalis subsp. Lactis, Bifidobacterium breve, Bifidobacterium longum, Lactobacillus gasseri, Lactobacillus casei, Lactobacillus rhamnosus) - 1 capsule/day

Outcomes

Primary Outcome Measures

Fecal Microbiota
analysis method: 16s rRNA sequencing and bioinformatics analysis. Reported measure: taxonomic profiles of the microbial populations (operational taxonomic units / OTUs)
SCFA
Acetate, propionate, isobutyrate, butyrate and isovalerate (μmol/L)
Inflammatory parameters
Plasma LPS, adiponectin, leptin, resistin, IL-1, IL-6, IL-8, IL-10 and TNF-alpha concentrations (pg/mL)

Secondary Outcome Measures

Fasting insulin
μUI/mL
fasting blood glucose
mg/dL
HOMA-IR
HOMA-IR = [fasting blood glucose (mmol) x fasting insulin (UI/ml)] ÷ 22,5
Glycated hemoglobin
percentage (%)
Free Fat Acids
µmol/L
Triglycerides
mg/dL.
Total cholesterol
mg/dL
LDL-c
(Friedewald equation) LDL-c = total colesterol - HDL-c - Triglicerídeos/5 Reported measure: mg/dL
HDL-c
mg/dL
Bone densitometry
Dual X-ray Absorptiometry (DXA). Reported measure: T-score and Z-score
Body weight (kg)
kilograms
Waist circumference (cm)
centimeters (cm)
Body mass index (BMI)
In metric units: BMI (kg/m²) = weight (kg) ÷ height² (meters). Reported measure: kg/m².
Total Body Fat Percentage (%BF)
Dual X-ray Absorptiometry (DXA). Reported measure: Total Body Fat Percentage (%BF)
Fat Mass Index (FMI)
Dual X-ray Absorptiometry (DXA) - Fat Mass Index (FMI) - the total amount of fat (in kilograms) relative to the height (in meters²)
Total Body lean mass Percentage (%)
Dual X-ray Absorptiometry (DXA) - Total Body lean mass Percentage (%): The percent of the body that is not composed of fat.

Full Information

First Posted
June 5, 2022
Last Updated
March 27, 2023
Sponsor
Universidade Federal de Santa Catarina
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1. Study Identification

Unique Protocol Identification Number
NCT05418179
Brief Title
Effect of Probiotic Supplementation on Fecal Microbiota, Nutritional Status, Metabolic and Inflammatory Parameters in Patients With Type 2 Diabetes Mellitus
Official Title
Effect of Probiotic Supplementation on Fecal Microbiota, Nutritional Status, Metabolic and Inflammatory Parameters in Patients With Type 2 Diabetes Mellitus: Study Protocol for a Triple-blind Controlled Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Catarina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of probiotic supplementation on fecal microbiota, nutritional status, metabolic and inflammatory parameters in patients with type 2 diabetes mellitus. Study hypothesis: Supplementation of multispecies probiotic (Bifidobacterium Lactis, B. brebe, B. longum, Lactobacillus gasseri, L. casei, L. rhamnosus) during 12 weeks improves the the fecal microbiota composition and promotes reduction of plasma/serum levels of acute phase proteins, cytokines, metabolic and anthropometric parameters in individuals with type 2 diabetes mellitus.
Detailed Description
The purpose of this study is to evaluate the effect of multispecies probiotic supplementation (specifically designed for the present study) on fecal microbiota, nutritional status, metabolic and inflammatory parameters in patients with type 2 diabetes mellitus (T2DM). Adult individuals (35 to 75 years old) of both sexes with T2DM (diagnosed at least 1 year ago), body mass index from 25.00 kg/m² to 39.99 kg/m², glycated hemoglobin ≤ 9.0% and using metformin will be invited to participate in this randomized, placebo-controlled, triple-blind study. The participants will be randomized into two groups: G1 - probiotic group and G2 - control group (placebo). The study will consist of two experimental time points: M0 - baseline and start of supplementation; M1 - after 12 weeks of the first outpatient visit and start of supplementation. In the two experimental moments, individual fecal samples will be obtained for analysis of the fecal microbiota; The metabolic parameters will be assessed by determination of circulating levels of SCFA, FFA, insulin, fasting glucose and glycated hemoglobin, HOMA-IR; Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides; the inflammatory response will be assessed by determination of plasma indicadors (LPS, Adiponectina, IL-10, IL-1, IL-6, TNF- α, Leptina, Resistina) ; besides the evaluation of indicators of nutritional status (bone densitometry with body composition and anthropometric measurements). The primary endpoint will be the fecal microbiota composition, SCFA concentrations and the inflammatory parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Study participants and researchers were masked over consumption and distribution of supplementation, respectively. Laboratory technicians who performed the blood collection were also masked as to the distribution of supplementation. Supplements and placebo were pre-packaged by the supplier in opaque and closed sachets with randomization codes, being identical in physical appearance, taste and color. Supplement identification codes were only disclosed by the supplier after statistical analysis of study data.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin (1 capsule/day)
Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
Probiotic (Bifidobacterium animalis subsp. Lactis, Bifidobacterium breve, Bifidobacterium longum, Lactobacillus gasseri, Lactobacillus casei, Lactobacillus rhamnosus) - 1 capsule/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
Probiotic (Bifidobacterium animalis subsp. Lactis, Bifidobacterium breve, Bifidobacterium longum, Lactobacillus gasseri, Lactobacillus casei, Lactobacillus rhamnosus) - 1 capsule/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Maltodextrin (1 capsule/day)
Primary Outcome Measure Information:
Title
Fecal Microbiota
Description
analysis method: 16s rRNA sequencing and bioinformatics analysis. Reported measure: taxonomic profiles of the microbial populations (operational taxonomic units / OTUs)
Time Frame
12 weeks compared to baseline
Title
SCFA
Description
Acetate, propionate, isobutyrate, butyrate and isovalerate (μmol/L)
Time Frame
12 weeks compared to baseline
Title
Inflammatory parameters
Description
Plasma LPS, adiponectin, leptin, resistin, IL-1, IL-6, IL-8, IL-10 and TNF-alpha concentrations (pg/mL)
Time Frame
12 weeks compared to baseline
Secondary Outcome Measure Information:
Title
Fasting insulin
Description
μUI/mL
Time Frame
12 weeks compared to baseline
Title
fasting blood glucose
Description
mg/dL
Time Frame
12 weeks compared to baseline
Title
HOMA-IR
Description
HOMA-IR = [fasting blood glucose (mmol) x fasting insulin (UI/ml)] ÷ 22,5
Time Frame
12 weeks compared to baseline
Title
Glycated hemoglobin
Description
percentage (%)
Time Frame
12 weeks compared to baseline
Title
Free Fat Acids
Description
µmol/L
Time Frame
12 weeks compared to baseline
Title
Triglycerides
Description
mg/dL.
Time Frame
12 weeks compared to baseline
Title
Total cholesterol
Description
mg/dL
Time Frame
12 weeks compared to baseline
Title
LDL-c
Description
(Friedewald equation) LDL-c = total colesterol - HDL-c - Triglicerídeos/5 Reported measure: mg/dL
Time Frame
12 weeks compared to baseline
Title
HDL-c
Description
mg/dL
Time Frame
12 weeks compared to baseline
Title
Bone densitometry
Description
Dual X-ray Absorptiometry (DXA). Reported measure: T-score and Z-score
Time Frame
12 weeks compared to baseline
Title
Body weight (kg)
Description
kilograms
Time Frame
12 weeks compared to baseline
Title
Waist circumference (cm)
Description
centimeters (cm)
Time Frame
12 weeks compared to baseline
Title
Body mass index (BMI)
Description
In metric units: BMI (kg/m²) = weight (kg) ÷ height² (meters). Reported measure: kg/m².
Time Frame
12 weeks compared to baseline
Title
Total Body Fat Percentage (%BF)
Description
Dual X-ray Absorptiometry (DXA). Reported measure: Total Body Fat Percentage (%BF)
Time Frame
12 weeks compared to baseline
Title
Fat Mass Index (FMI)
Description
Dual X-ray Absorptiometry (DXA) - Fat Mass Index (FMI) - the total amount of fat (in kilograms) relative to the height (in meters²)
Time Frame
12 weeks compared to baseline
Title
Total Body lean mass Percentage (%)
Description
Dual X-ray Absorptiometry (DXA) - Total Body lean mass Percentage (%): The percent of the body that is not composed of fat.
Time Frame
12 weeks compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age from 35 to 75 years old; Individuals diagnosed with type 2 diabetes mellitus (at least 1 year ago); Body mass index from 25.00 kg/m² to 39.99 kg/m²; Glycated hemoglobin ≤ 9.0% ; Using metformin, combined or not with other antidiabetic drugs Exclusion Criteria: Previous bowel diseases (inflammatory bowel disease and irritable bowel syndrome); or previous gastrointestinal surgery (eg, colectomy, gastrectomy) Intolerances and ∕ or food allergies with a previous medical diagnosis (eg lactose intolerance or celiac disease); Glomerular filtration rate <30 ml/min/1.73m²; inflammatory diseases and immunodeficiencies; Diagnosis of autonomic neuropathy with gastrointestinal involvement such as: diabetic gastroparesis, diabetic enteropathy (diarrhea) or colonic hypomotility (constipation); Hospital admission and/or use of anti-inflammatory drugs (non-hormonal and corticosteroids) up to 1 month before the study; and ∕or use of antibiotics up to 3 months before the study; Regular use of laxatives, opioid narcotic analgesics or appetite suppressants; Current or previous use (up to 1 month) of prebiotics, probiotics, symbiotics or products enriched with these food supplements; Intolerance to prebiotics, probiotics or symbiotics; Pregnant or breastfeeding; Follow-up of a diet, guided by a nutritionist, for weight loss or gain up to 1 month before the study or current follow-up of unusual diets (eg vegetarian, macrobiotic, paleolithic); Alcohol consumption (> 1 drink/day or 14g of alcohol for women; >2 drinks/day or 28 grams of alcohol for men); use of illicit drugs and smokers; Change of lipid-lowering and/or antidiabetic drugs in the last 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erasmo Trindade, PhD
Phone
+55 48 3721-3489
Email
erasmotrindade@gmail.com
Facility Information:
Facility Name
Polydoro Ernani de São Thiago University Hospital
City
Florianópolis
State/Province
Santa Catarina
ZIP/Postal Code
88036-800
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erasmo BSM Trindade, PhD
Phone
+55 48 3721-3489
Email
erasmotrindade@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Probiotic Supplementation on Fecal Microbiota, Nutritional Status, Metabolic and Inflammatory Parameters in Patients With Type 2 Diabetes Mellitus

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